(28 days)
Not Found
No
The description details a mechanical balloon catheter and its physical components. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device details explicitly state its intended use for "balloon dilatation of lesions in the peripheral vasculature," which is a direct therapeutic intervention to treat a medical condition.
No
This device is a therapeutic device (balloon catheter for dilatation), not a diagnostic device. It is used to treat lesions, not to diagnose them.
No
The device description clearly details a physical balloon catheter with a braided shaft, balloon, nitinol constraining structure, and a plastic hub with ports. This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The provided information clearly describes a physical device (a balloon catheter) that is inserted into the body (peripheral vasculature) to perform a therapeutic procedure (balloon dilatation). This is an in vivo procedure, not an in vitro diagnostic test.
The device is a therapeutic medical device used for treating blockages in blood vessels, not for diagnosing conditions by testing samples.
N/A
Intended Use / Indications for Use
The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The Chocolate PTA Balloon Catheter is an "over-the-wire" balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The product family consists of 0.014" and 0.018" systems that are compatible with 0.014" and 0.018" guidewires, respectively. Overall catheter lengths range from 120-150 cm.
The distal end of the catheter has a semi-compliant balloon that expands to known diameters at specific pressures. The balloon is constrained by a nitinol constraining structure (CS) which provides fast deflation and uniform re-wrap. Upon deflation, the CS is removed from the vessel along with the balloon catheter. The balloon is available in multiple sizes and contains two radiopaque markers to assist with positioning. The proximal end of the device is a common balloon catheter design of a braided shaft connected to a plastic hub and strain relief. The hub has two ports; the balloon port is used to inflate the balloon and the guidewire port connects to the guidewire lumen.
The Chocolate PTA balloon catheter is intended for single-use only and is provided sterile and non-pyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Packaging validation, packaging aging, and sterilization testing were performed on the subject Chocolate PTA Balloon Catheter with a 72-page IFU and eIFU leaflet to resemble worst-case packaging configuration. All units passed their respective testing requirements and no additional risks resulted from the changes to the IFU. Medtronic is also performing 3-year real-time aging tests to confirm the accelerated aging results.
New biocompatibility testing was completed in report D00557778 for supplier and material changes. The subject Chocolate PTA Balloon Catheter was subjected to the following biocompatibility testing: Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute systemic toxicity, Material mediated pyrogenicity, Hemocompatibility testing. Based on the biocompatibility data gathered, it was concluded that the subject Chocolate PTA balloon catheter, as guided by ISO 10993-1:2018, passed the required tests and does not present a patient health hazard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
December 15, 2021
Medtronic, Inc. Laura Hanson Regulatory Affairs Specialist 2300 Berkshire Lane North, Suite 5 Plymouth, Minnesota 55441
Re: K213631
Trade/Device Name: Chocolate PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT Dated: November 15, 2021 Received: November 17, 2021
Dear Laura Hanson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213631
Device Name Chocolate PTA Balloon Catheter
Indications for Use (Describe)
The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Medtronic
Special 510(k) Summary Chocolate PTA Balloon Catheter
| 510(k) Summary | This summary is being submitted in accordance with the
requirements of 21 CFR § 807.92. | | |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Applicant/ Submitter | Medtronic, Inc.
2300 Berkshire Lane North, Suite 5
Plymouth, MN 55441
Tel: 763-591-3024 | | |
| Contact Person | Laura Hanson
Regulatory Affairs Specialist
Tel: 763-591-3024
Email: laura.r.hanson@medtronic.com | | |
| Secondary Contact Person | Brandon Casa de Calvo
Regulatory Affairs Senior Manager
Tel: 763-591-3024
Email: brandon.m.casa.de.calvo@medtronic.com | | |
| Date Prepared | November 9, 2021 | | |
| Device Trade Name | Chocolate PTA Balloon Catheter | | |
| Submission 510(k) Number | K213631 | | |
| Device Common Name | Angioplasty Catheter | | |
| Classification Name | Percutaneous catheter, Cardiovascular | | |
| Regulation Number | 21 CFR 870.1250 | | |
| Classification | Class II | | |
| Classification Panel | Cardiovascular | | |
| Product Code | LIT | | |
| Primary Predicate Device | Chocolate PTA Balloon Catheter | | |
| Primary Predicate 510(k)
Number | K130414 | | |
| Primary Predicate
Regulation Number | 21 CFR 870.1250 | | |
| Indications for Use | The Chocolate PTA balloon catheter is intended for balloon
dilatation of lesions in the peripheral vasculature, including the
iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries. | | |
| Device Description | The Chocolate PTA Balloon Catheter is an "over-the-wire" balloon
dilatation catheter with a braided shaft and an atraumatic tapered tip.
The product family consists of 0.014" and 0.018" systems that are
compatible with 0.014" and 0.018" guidewires, respectively. Overall
catheter lengths range from 120-150 cm. | | |
| | The distal end of the catheter has a semi-compliant balloon that
expands to known diameters at specific pressures. The balloon is
constrained by a nitinol constraining structure (CS) which provides
fast deflation and uniform re-wrap. Upon deflation, the CS is removed
from the vessel along with the balloon catheter. The balloon is
available in multiple sizes and contains two radiopaque markers to
assist with positioning. The proximal end of the device is a common
balloon catheter design of a braided shaft connected to a plastic hub
and strain relief. The hub has two ports; the balloon port is used to
inflate the balloon and the guidewire port connects to the guidewire
lumen. | | |
| | The Chocolate PTA balloon catheter is intended for single-use only
and is provided sterile and non-pyrogenic. | | |
| Comparison of
Technological
Characteristics | The subject Chocolate PTA Balloon Catheter components will have
minor changes to the materials used which are equivalent to the
materials used in the predicate device. These material changes are
being implemented alongside supplier changes to ensure a more robust
supply chain.
Additionally, in order to support EU MDR requirements, Chocolate's
IFU is being changed in size and stitching to accommodate additional
global language requirements with a change to eliminate renal arteries
from the indications for use.
The subject Chocolate device shares the following technological
characteristics with the predicate device. These characteristics are
considered identical between the subject and predicate. | | |
| | ● Intended Use | | |
| | ● Principle of Operation | | |
| | ● Balloon technical specifications including available
diameters, lengths, materials, radiopaque markers, rated burst
pressure, nominal pressure and constraining structure material | | |
| | ● Catheter technical specifications including available lengths,
guidewire compatibility, introducer compatibility, and all
materials except for the inner member component materials
listed in Table 7.1. | | |
| | ● Packaging materials | | |
| | ● Testing and Compliance to ISO 10993 and ISO 11135-1 | | |
| Table 7.1: Chocolate PTA Balloon Catheter Predicate to Subject Equivalencies | | | |
| | | | |
4
5
● Sterilization Method
Table 7.1 below outlines the characteristics between the predicate and subject Chocolate PTA Balloon Catheters that are not identical but are considered similar and equivalent.
| Predicate Device | Subject Device | |
|---|---|---|
| Device Name | Chocolate PTA Balloon Catheter | |
| (Primary Predicate) | Chocolate PTA Balloon Catheter | |
| Indications for | ||
| Use | The Chocolate®* PTA Balloon | |
| Catheter is intended for balloon | ||
| dilatation of lesions in the peripheral | ||
| vasculature, including the iliac, | ||
| femoral, ilio-femoral, popliteal, | ||
| infra-popliteal, and renal arteries. | The Chocolate™* PTA balloon | |
| catheter is intended for balloon | ||
| dilatation of lesions in the peripheral | ||
| vasculature, including the iliac, | ||
| femoral, ilio-femoral, popliteal, and | ||
| infra-popliteal arteries. | ||
| Inner Member | ||
| component - outer | ||
| layer resin | Resin Change | |
| Inner Member materials: | ||
| Outer layer NY-L25 Grilamid (Grilamid | ||
| L25 natural) Colorant 833125 Transblue FDA Inner layer PE-LR734 HDPE LR7340-01 | ||
| Petrothene High Density Intermediate layer (tie-layer) | ||
| PE-Orevac 18300 | Resin Change | |
| Inner Member materials: | ||
| Outer layer NY-L25 Grilamid (Grilamid L25 | ||
| natural) Inner layer PE-LR734 HDPE LR7340-02 | ||
| Petrothene High Density Intermediate layer (tie-layer) | ||
| PE-Orevac 18300M | ||
| IFU | ||
| (specifications) | Folded & stapled | |
| 8.5" x 11.0" | Saddle stitch booklet | |
| 10" x 10" | ||
| Compliance Card | 5.0" x 6.0" | 4.0" x 5.0" |
| Artwork Update | ||
| Pouch Label | ||
| (dimensions) | 6.25" x 8.5" | 6.38" x 8.00" |
| Carton Label | ||
| (dimensions) | 6.25" x 10.40" | 6.61" x 8.75" |
Performance data Due to the physical differences between the subject device IFU and predicate device IFU, the subject Chocolate PTA Balloon Catheter underwent packaging validation, packaging aging, and sterilization testing with a 72-page IFU and eIFU leaflet to resemble worst-case packaging configuration. This 72-page test IFU and eIFU leaflet exceeds the size of the IFU and eIFU leaflet in the subject device. All units passed their respective testing requirements and no additional risks resulted from the changes to the IFU. Medtronic is also performing 3year real-time aging tests to confirm the accelerated aging results. See
6
Section 16, Table 16.2 for a summary of completed testing for the subject Chocolate PTA Balloon Catheter IFU changes.
The proposed changes in this submission do not require a change in the sterilization process or equipment (sterilization assurance level: 10-6). Due to successfully completing the testing described in section 15.3.8, it was determined that no sterilization process changes are required due to the proposed changes.
To support the safety and performance of the subject Chocolate PTA Balloon Catheter device, new biocompatibility testing was completed in report D00557778. Biocompatibility Evaluation Report for Chocolate PTA Balloon Catheter for Supplier and Material Changes. The subject Chocolate PTA Balloon Catheter was subjected to the following biocompatibility testing:
- Cytotoxicity ●
- Sensitization ●
- Irritation/intracutaneous reactivity
- Acute systemic toxicity
- Material mediated pyrogenicity
- o Hemocompatibility testing
Based on the biocompatibility data gathered, it was concluded that the subject Chocolate PTA balloon catheter, as guided by ISO 10993-1:2018, passed the required tests and does not present a patient health hazard. As a result of this testing and the associated risk analysis, it was determined that there are no new or increased biocompatibility concerns.
The technological characteristics and performance criteria of the Chocolate PTA Balloon Catheter are equivalent to the predicate device, and the subject device performs in a manner equivalent to the predicate device currently on the market.
- Based on the intended use, technological characteristics, device design, Conclusion operating principle, shelf-life testing, packaging validation and sterilization testing. Medtronic concludes the subject Chocolate PTA Balloon Catheter to be substantially equivalent to the predicate Chocolate PTA Balloon Catheter, K130414.